Clinical Trial COGACNS0927
A Phase 1/2 Study of Suberoylanilide Hydroxamic Acid (SAHA, Vorinostat) and Local Irradiation, Followed by Maintenance SAHA in Children with Newly Diagnosed Diffuse Intrinsic Pontine Gliomas (DIPG)
- Protocol No. COGACNS0927
- Open Date: 03/22/2012
- Staging: Phase I/II
- Age Group: Both Child and Adult
- Scope: National
- Objective: 1 - To estimate the maximum tolerated dose (MTD) or recommend a Phase 2 dose of vorinostat given concurrently with radiation in children with newly diagnosed diffuse intrinsic pontine glioma (DIPG). 2 - To define and describe the toxicities of vorinostat given concurrently with radiation in children with newly diagnosed DIPG. 3 - To determine, in the context of this phase I/II trial, the anti-tumor activity of combining vorinostat with radiation, followed by maintenance vorinostat for twelve courses, in children with newly diagnosed DIPG, as measured by 12-month event-free survival (EFS) and overall survival (OS). 4 - To determine the toxicities of vorinostat for 12 additional courses after completion of vorinostat and radiation.
- Disease Sites: Pediatric Solid Tumors
- Therapies: Chemotherapy - cytotoxic; Radiotherapy
- Drugs: Vorinostat (ZOLINZA)
- Participating Institutions: Vanderbilt University
- Secondary Protocol No: ACNS0927
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